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Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study (TRIMS A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01006941
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : November 10, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Biological: Trichuris suis ova Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study
Study Start Date : May 2010
Primary Completion Date : January 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Trichuris suis ova Biological: Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks
Other Name: TSO

Outcome Measures

Primary Outcome Measures :
  1. MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions [ Time Frame: every 3. week. 3 MRI before treatment and 4 MRI during and after treatment ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age between 19 and 55 years
  • relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive MS with relapses
  • duration of the disease of at least 1 year
  • no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months
  • at least 2 documented relapses during the last 24 months with the last relapse within the last 12 months

Exclusion Criteria:

  • pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients
  • relapse in the last month prior enrolment
  • treatment with steroids in the last 30 days
  • previous treatment with mitoxantroneduring the last year
  • previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation
  • treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment
  • cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension
  • diabetes mellitus and other autoimmune diseases
  • history of renal insufficiency
  • stay in tropical areas during the last 3 months
  • eosinophilia in the blood (> 0,45 billion/l)
  • concurrent systemic infections
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006941

Danish Multiple Sclerosis Center, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Statens Serum Institut
Copenhagen University Hospital, Hvidovre
OvaMed GmbH
Study Director: Per S Sørensen, Professor Rigshospitalet, Danish Multiple Slerosis Research Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana Voldsgaard, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01006941     History of Changes
Other Study ID Numbers: Rigshospitalet, DMSC
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by Ana Voldsgaard, Rigshospitalet, Denmark:
Multiple sclerosis
Trichuris suis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases